Sushrut BhattDirector Medical Governance Quality & Risk Management
GlaxoSmithKline Pharmaceuticals Limited
• Defining role-specific goals and metrics in quality assurance
• How can you track PV SOPs and update working documents in a more proactive manner?
• Implementing a Quality Management System incorporating Corrective and Preventive action plans (CAPAs)
• Utilizing appropriate assessment tools for evaluating drug databases: How do you validate IT systems and applications?
• Exploring the role of the Qualified Person for Pharmacovigilance (QPPV) in Asia as a single point of contact
Key updates on an ongoing 2-year global project to establish qualified PV affiliates
How do you ensure visibility and maintain quality in an MNC with more than 100 offices across the world
Establishing an in-house standardised monitoring system with scalable heatmap
Change management and integrating a global PV system into the company corporate quality system
Ensuring clear metrics with agreed definitions and methodology